It is recognized that stem cell therapies have had beneficial healing effects in relation to wound healing. The wound, whether caused by trauma or as part of a surgical procedure, appears and has been proven to heal more rapidly with the beneficial use of sutures laden with stem cells. As early as Jan. 16, 2001 a patent was granted and publicly released called Biomatrix for soft tissue regeneration using mesenchymal stem cells which was U.S. Pat. No. 6,174,333 B1. This work was in conjunction with Case Western University and Osiris Therapeutics Inc. and disclosed the manufacture of a mat sheet that was formed into a spiral roll with sutures extending from opposite roll ends to form an implant laden with stem cells.
The implant for repair of a tissue defect used a plurality of physiologically compatible load-bearing sutures for securing under tension tissue adjacent to the defect to be repaired, the sutures for supporting a tissue reparative cell mass in the defect and a tissue reparative cell mass supported thereby. The sutures had a central portion encapsulated in a cell containing matrix which is contracted under a tensile load by the cells thereof and formed into a mat sheet during the contraction. Spring metal wires hold the sutures in tension during the contraction. The matrix was a collagen gel or other material which the cells contract, the cells comprising human mesenchymal stem cells.
Latter inventors working for Bioactive Surgical, Inc. disclosed in US 2009/0318962 surgical sutures incorporated with cells or other bioactive materials. The stem cell laden sutures allowed medical personnel to reintroduce bioactive material extracted from a patient or the allogenic equivalents to a wound or surgical site.
All of this work involved using stem cell laden sutures to accelerate wound healing typically and were directed to soft tissue.
In WO 2010054527 the use of stem cells was taught to be beneficial in jaw bone prosthesis. These prostheses. These prostheses were implants made of human tissue taken from cadavers.
In U.S. Pat. No. 6,254,637 taught that a very thin artificial cornea was implanted on the surface of an eye and covered by an amnion sheet in an attempt to promote a stable graft.
As the science of stem cell production and manufacture has been evolving, the technology has developed techniques to provide methods for culturing stem cells with the use of amnion membranes as in U.S. Pat. No. 7,923,246 or as taught in US 2009/0175954A and US 2009/0238855 the manufacture of stem cell laden sheets have been successfully produced.
This ability to provide sheets or even coatings of stem cell laden material has given the surgeon a new tool to use in combination with soft tissue or organ implants to reduce rejection and accelerate healing. Collagen laden stem cell sutures are available for artery or vein repair and the wraps have been proposed to accelerate bone fracture healing. In all of these uses it has been proposed that stem cells could help in tissue to cellular tissue regeneration and healing.
The present invention proposes a new and beneficial use of stem cell coatings or preferably stem cell wraps in pliable sheet form as disclosed and described below.